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Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal's Web site (www.journaladdictionmedicine.com).

This article is the summary of a supplement to this issue titled The Appropriate Use of Drug Testing in Clinical Addiction Medicine.

Abstract

Biological drug testing is a tool that provides information about an individual's recent substance use. Like any tool, its value depends on using it correctly; that is, on selecting the right test for the right person at the right time. This document is intended to clarify appropriate clinical use of drug testing in addiction medicine and aid providers in their decisions about drug testing for the identification, diagnosis, treatment, and recovery of patients with, or at risk for, addiction. The RAND Corporation (RAND)/University of California, Los Angeles (UCLA) Appropriateness Method (RAM) process for combining scientific evidence with the collective judgment of experts was used to identify appropriate clinical practices and highlight areas where research is needed. Although consensus panels and expert groups have offered guidance on the use of drug testing for patients with addiction, very few addressed considerations for patients across settings and in different levels of care. This document will focus primarily on patients in addiction treatment and recovery, where drug testing is used to assess patients for a substance use disorder, monitor the effectiveness of a treatment plan, and support recovery. Inasmuch as the scope includes the recognition of addiction, which often occurs in general healthcare settings, selected special populations at risk for addiction visiting these settings are briefly included.

RATIONALE

The purpose of the American Society of Addiction Medicine (ASAM) document Appropriate Use of Drug Testing in Clinical Addiction Medicine is to provide guidance about the effective use of drug testing in the identification, diagnosis, treatment, and promotion of recovery for patients with, or at risk for, addiction. This document draws on existing empirical evidence and clinical judgment on drug testing with the goal of improving the quality of care that people with addiction receive.

Drug testing uses a biological sample to detect the presence of a specific drug (or drugs) as well as drug metabolites that remain in the body following use for a window of time. No universal standards exist today in clinical drug testing for addiction identification, treatment, medication monitoring, or recovery. Relatedly, there is very limited empirical evidence about whether the use of drug testing in addiction treatment settings leads to improved clinical outcomes.

DOCUMENT FOCUS

This document focuses on when, where and how often it is appropriate to perform drug testing in the identification, treatment and recovery of patients with, or at risk for, addiction. These recommendations are not meant to be clinical practice guidelines, which typically focus on either more generalized or disease-specific recommendations. ASAM recognizes that drug testing is used in other contexts (eg, criminal justice, workplace and pain management settings). ASAM's intent with this document, however, is to focus primarily on patients in addiction treatment and recovery, where drug testing is used to assess the patient for a substance use disorder (SUD), monitor the effectiveness of their treatment plan and support recovery, and to also focus on selected special populations at risk for addiction in general healthcare settings. Although ASAM acknowledges that these recommendations may be applied to other settings where drug testing is utilized, note that the materials reviewed and methodology used were restricted to the populations and settings described.

TARGET POPULATION

This appropriateness document is intended for addiction specialists and for all providers utilizing drug testing in the context of the identification, treatment and monitoring of patients with, or at risk for, addiction. This document will also be useful for physicians and other providers concerned about the possibility of addiction in their patient population.

RECOMMENDATION DEVELOPMENT PROCESS

The RAND Corporation (RAND)/University of California, Los Angeles (UCLA) Appropriateness Method (RAM) provides a specific process for combining the best available scientific evidence with the collective clinical judgment of field experts to arrive at recommended practices (Fitch et al., 2001). The RAM is ideal for the identification of underuse or overuse of specific clinical procedures or tests, as well as in situations where rigorous clinical trials are lacking. The use of the RAM produced a set of appropriateness statements regarding the use of drug testing in the identification, diagnosis, treatment, and promotion of recovery for patients with, or at risk for, addiction.

ASAM's Quality Improvement Council (QIC) was the oversight committee for the development of the appropriateness document. The QIC appointed a 10-member expert panel to participate throughout the development process, rate treatment scenarios, and review the draft document. In selecting the panel members, the QIC made every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of relationships with industry and other entities among members of the expert panel. All QIC members, expert panel members, and external reviewers of the document were required to disclose all current related relationships, which are presented in the Supplemental Digital Content, http://links.lww.com/JAM/A56.

The expert panel was comprised experts and researchers from multiple disciplines, medical specialties, and subspecialties, including academic research, internal medicine, adolescent medicine, pain medicine, emergency medicine, medical toxicology, anesthesiology, psychiatry, and obstetrics/gynecology. Physicians with both allopathic and osteopathic training were represented. Furthermore, the panel members represented a range of practice settings including opioid treatment programs (OTPs), physician health programs, private practice, and academic medical centers. The expert panel was assisted by a technical team from the Institute for Research, Education and Training in Addictions (IRETA). The expert panel moderator and medical advisor was selected by the IRETA project team and approved by the QIC.

EVIDENCE REVIEW AND GRADING

Existing clinical guidelines offering guidance on the use of drug testing for patients with, or at risk for, addiction were located and reviewed. Overall, the review of existing guidelines revealed that numerous consensus panels and expert groups have offered guidance on the use drug testing for patients with addiction. However, with the notable exceptions of the Substance Abuse and Mental Health Services Administration's (SAMHSA) Treatment Improvement Protocols (TIP) 40 and 43 (CSAT, 2007; CSAT, 2012), very few of these guidelines address drug testing in the context of patient levels of care. Publications by authoritative professional societies, including the American Society of Addiction Medicine (ASAM), the American Academy of Pediatrics (AAP), and the American College of Obstetrics and Gynecologists (ACOG) were also consulted. Although not typically evidence-based, a representative sample of payer policies was also consulted for information about the patient populations and types and frequency of drug testing that are currently reimbursed in clinical care. See the Supplemental Digital Content, http://links.lww.com/JAM/A56 for a complete list of clinical guidelines reviewed.

A review of empirical evidence regarding the use of drug testing in the identification, treatment, and monitoring of patients with, or at risk for, addiction was conducted. Relevant research was identified via a PubMed MeSH term search for Substance-related Disorders and Substance Abuse Detection articles published in the previous 10 years, capturing the most up-to-date findings for a field defined by rapidly advancing technological innovations. Important earlier articles were identified through reverse citation search. Given the relative paucity of research directly examining drug testing in SUD populations and settings, the review was not limited to randomized controlled trials or similarly rigorous methodologies; it included cohort studies and case studies. Of the 866 articles identified, 113 were retained following a title and abstract review for relevance to the topic of biological detection of addictive substances in an appropriate population or setting. See the Supplemental Digital Content, http://links.lww.com/JAM/A56 for a complete list of articles reviewed.

Overall, the literature review revealed that drug testing has rarely been examined for its value as a clinical intervention or as a differential source of information. Many research studies include drug testing as an outcome measure of treatment adherence or progress, but few examined whether and how drug testing itself works to improve outcomes for patients with, or at risk for, addiction.

RAND/UCLA Appropriateness Method

Statements pertaining to the appropriate use of drug testing in the identification, treatment, and monitoring of patients with, or at risk for, addiction were derived from the review of existing guideline publications, payer policies, and literature. There were some clinical areas identified by the project team and medical advisor relevant to addiction treatment settings where existing clinical recommendations or adequate empirical evidence were not found (eg, certain levels of care). In these situations, appropriateness statements were generated in conjunction with the medical advisor and the lack of the existing evidence was clearly documented.

Each appropriateness statement was rated by the project team on degree of clinical consensus from previous guidelines and quality of empirical evidence. A high clinical consensus rating was reserved for statements supported by multiple sources. A high empirical evidence rating was reserved for statements emerging from multiple studies using rigorous study methodology (eg, randomized controlled trials). The statements and supporting evidence ratings were organized into a table, which served as the foundation for rating by the expert panel. A background article discussing each appropriateness statement and relevant clinical or empirical evidence was also developed and provided to the expert panel members.

Each panel member rated the appropriateness of each statement on a 9-point scale where 1 = extremely inappropriate and 9 = extremely appropriate. Appropriateness refers to whether the expected benefit of following the guidance offered by a statement outweighs any anticipated risks, irrespective of cost. The experts were asked to use their own best clinical judgment (rather than perception of what other experts might say) of appropriateness for an average patient presenting to an average provider who performs drug testing in an average setting that provides care for patients with addiction.

Statements with median scores in the 1 to 3 range were classified as inappropriate, those in the 4 to 6 range as uncertain, and those in the 7 to 9 range as appropriate. Consensus was defined as a statement that received no more than 2 ratings outside of the median score range. This cutoff for disagreement is commonly used for panel sizes of 8 to 10 members.

Expert Panel Meeting

The 10-member expert panel came together for a 2-day meeting to discuss their ratings, focusing on statements that were rated uncertain or about which they disagreed. The goal of the discussion was to discern whether uncertain and divergent ratings were due to real clinical disagreement or “artefactual” disagreement, such as fatigue while completing the rating instrument or misunderstanding of the statements. The expert panel was encouraged to modify statements for clarity and suggest additional statements during the discussion.

After the meeting, each expert rated the appropriateness of the subset of previously uncertain and disagreed upon statements, as well as the new statements that were constructed, on a 9-point scale, where 1 = extremely inappropriate and 9 = extremely appropriate. A table of the statements, their final ratings and associated evidence ratings is included in the Supplemental Digital Content, http://links.lww.com/JAM/A56.

COMMENTS AND MODIFICATION

The first draft of the appropriateness document was created and sent to the expert panel and ASAM staff. During a subsequent teleconference held in January 2017, ASAM shared feedback with the project team regarding the document's organization, and a revised version was provided. ASAM directed an external review of the appropriateness document, which consisted of input from ASAM members and stakeholders including experts from the addiction treatment community, professional societies, and the public. The external review period was conducted from February 3, 2017, to February 28, 2017. Further edits to the appropriateness document were made on the basis of this feedback.

CLINICAL RECOMMENDATIONS

The clinical recommendations generated by the RAM and external review process are listed below. Additional discussion and references are included in the Supplemental Digital Content, http://links.lww.com/JAM/A56.

PART 6: SPECIAL POPULATIONS

Adolescents

Adolescents and Self-Reported Substance Use

Adolescents and Home Testing Kits

Adolescent Consent

Adolescent Confidentiality

Test Choice

Responding to Positive Test Results

Pregnant Patients

Consequences and Confidentiality

Screening, Assessment, and Monitoring

Patient-Provider Relationship

Test Considerations

Test Results

People in Recovery

Health and Other Professionals

RESEARCH RECOMMENDATIONS

This document is intended to provide guidance about the effective use of drug testing in the identification, diagnosis, treatment, and promotion of recovery for patients with, or at risk for, addiction. There were areas with insufficient evidence to make a recommendation, and/or a recommendation was not rated with agreement by the expert panel members. These areas were translated into the research recommendations below.

PART 1: PRINCIPLES OF DRUG TESTING IN ADDICTION TREATMENT

Further research is needed on whether and how drug testing can be used to determine efficacy of and adjustments to treatment plans.

Additional research is needed on the relationship between drug testing and functional status and other addiction treatment outcomes. Further research should include mediators and moderators of the relationship.

More research is needed on the utility of clinical drug testing in populations where SUD is often identified, including primary care, emergency room, and pain management patients.

PART 2: PROCESS OF DRUG TESTING IN ADDICTION TREATMENT

Significantly more research is needed on optimal testing frequency as well as the relationship between specific frequency and duration of drug testing and treatment monitoring and outcomes.

Additional research is needed on how to utilize drug testing to detect novel and synthetic drugs (eg, cannabinoids, cathinones).

Although evidence suggests that random testing schedules are more effective than testing on a predictable timeline, further study is needed to determine whether there are situations where non-random testing is sufficient.

Further and ongoing research is needed on which drugs should be included in drug test panels.

Further research is needed on determinations of when a definitive test as follow-up or in place of a presumptive test should occur.

Additionally, more research is needed on the benefits of forgoing presumptive testing and beginning with definitive testing, and on discerning the roles of different kinds of definitive testing.

PART 3: ADDITIONAL CONSIDERATIONS FOR DRUG TESTING IN ADDICTION TREATMENT

More research on effective personnel training to increase the reliability of drug testing conducted at the point of care is needed.

The development of appropriate cutoffs for POCT needs more research. Though manufacturer recommended cutoffs are generally more appropriate for workplace rather than clinical drug testing, producing guidelines for a clinical setting requires more information.

Further research is needed on the effects of conducting onsite testing and interpretation versus routinely sending tests to a laboratory for results.

Further research on the impact of insurer regulations and restrictions on drug testing, addiction treatment, and overall healthcare costs would be useful.

PART 4: BIOLOGICAL MATRICES

Further research is needed to develop a protocol for evaluating sample tampering in urine drug testing. Further research is also needed to clarify what methods should be employed to verify specimen validity in alternative matrices.

Additional study is required to determine the detectability of cannabis use in multiple matrices, namely oral fluid and hair.

Research is lacking on which substances’ metabolites can be helpfully detected through hair testing. More information on false positives, environmental adulterants, and detection windows would be beneficial.

More research is needed on whether hair and nail testing is clinically useful in ascertaining substance use patterns and history.

More research is needed on the utility of sweat testing in addiction treatment settings.

Additional research is needed on oral fluid, including which specific drugs/metabolites oral fluid testing might best detect.

Further research on tobacco testing in the context of addiction treatment would be useful.

PART 5: SETTINGS

Further research is needed on the role of drug testing for identification of potential issues in primary care or other settings outside of addiction treatment such as mental health settings.

Before making any specific recommendations of frequency or duration specific to level of care, further research should occur.

Further research will be required to offer complete information regarding appropriate drug testing panels in OTS. The same applies to the role of drug testing in determining optimal dosing in the context of OTS.

In the context of OTS, further research is needed on frequency of drug testing and on response to drug testing results.

Further research is needed to determine whether testing frequency should vary between full agonists, partial agonists, and antagonists when treating addiction involving opioid use.

PART 6: SPECIAL POPULATIONS

Although it is agreed that instances exist where an adolescent ought to be drug tested regardless of their own desires, the exact circumstances would benefit from further refinement.

Further research is needed to determine what, if any, clinical benefit there is to routinely utilizing drug testing with pregnant women.

Additional research is needed on what methods might be utilized to test for identification of alcohol use during pregnancy.

Further research is needed on how widely the drug testing standards developed for Primary Health Providers could be applied to other addiction treatment programs.

APPLICABILITY AND IMPLEMENTATION ISSUES

This document is intended to aid providers in their clinical decision-making and patient management. The document strives to identify and define clinical decision-making junctures that meet the needs of most patients in most circumstances. Clinical decision-making should involve consideration of the quality and availability of expertise and services in the community wherein care is provided. In circumstances in which the document is being used as the basis for regulatory or payer decisions, improvement in quality of care should be the goal. Because lack of patient understanding and adherence may adversely affect outcomes, providers should make every effort to promote the patient's understanding of, and adherence to, prescribed and recommended pharmacological and psychosocial treatments and any associated testing. Patients should be informed of the risks, benefits, and alternatives to a particular treatment or test, and should be an active party to shared decision-making whenever feasible. Recommendations in this document do not supersede any federal or state regulation.

CONCLUSIONS

Drug testing should be a routine part of initial and ongoing patient assessment of recent substance use in all addiction treatment settings. Drug test results should be not be used as the sole determinant when making patient care decisions; instead, they should be used in conjunction with patients’ substance use self-reports, treatment history, psychosocial assessment, and physical examination. Drug testing should be included at intake to assist in a patient's initial assessment and treatment planning and as a routine part of ongoing assessment for substance use that could complicate treatment response and patient management. Test selections should be individualized based a patient's drug of choice, prescribed medications, and drugs commonly used in the patient's geographic location and peer group. Treatment setting factors such as opportunity for substance use, the need to maintain a drug-free therapeutic environment, ensuring adherence with prescribed medications and monitoring for possible diversion also play a role in test selection. Frequency of testing should be dictated by patient acuity and level of care and tests’ detection capabilities and windows of detection.